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Clinical Trials in France / NCT03357445
Active, not recruiting Not applicable

AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

NCT03357445 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2011-10-14
Last updated
2024-11-14

Condition(s) studied

Primary OsteoarthritisPost-Traumatic ArthritisInflammatory Joint DiseaseFemoral Neck FractureFemoral Head NecrosisSequelae From Previous Hip SurgeryOsteotomiesCongenital Hip Dysplasia

Investigational drug(s) / intervention(s)

Avantage Reload cup

Avantage Reload cup: Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty

Study summary

This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically * Primary osteoarthritis * Post-Traumatic arthritis * Inflammatory joint disease (e.g. Rheumatoid arthritis) * Femoral neck fracture * Femoral head necrosis * Sequelae from previous hip surgery, osteotomies, etc. * Congenital hip dysplasia Additional inclusion criteria include: * Male or female * 18 years of age or older * Subjects willing to return for follow-up evaluations * Subjects who read, understand study information and give written consent (specific local regulatory requirements) Exclusion Criteria: * Exclusion criteria should be in accordance with Contraindications for the AVANTAGE® RELOAD: Absolute contraindications include: * Infection * Sepsis * Severe muscular, neurological or vascular deficiencies of the extremity involved * Bone destruction or poor bone quality Additional contraindications include: * Subjects unable to co-operate with and complete the study * Dementia and inability to understand and follow instructions * Neurological conditions affecting movement * Patient over 18 under law supervision

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
CHU Cote de Nacre Caen France
Hôpital Renée Sabran Giens France
CHU Lapeyronie Montpellier France
Hospital Novo Mesto Novo Mesto Slovenia

More Zimmer Biomet trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03357445 on ClinicalTrials.gov ↗ ← All trials in France